Protagenic progresses PT00114 to multiple-dose Phase 1 clinical trial

Clinical Trial Progress: Protagenic Therapeutics has completed the first dose injection for all participants in the multiple-dose phase of its Phase I clinical trial for PT00114, with full dosing expected by the end of August.

Safety Data Timeline: Topline safety data from the trial is anticipated by the end of September, which will inform the transition to Phase 2 efficacy studies planned for early 2026.

Innovative Therapy Approach: PT00114 is based on a naturally occurring brain hormone and aims to directly modulate maladaptive stress responses, offering a new treatment strategy for anxiety, depression, addiction, and PTSD.

Previous Trial Success: The current multiple-dose study follows a successful single ascending dose trial that confirmed PT00114's favorable safety and tolerability profile, supporting its potential in treating mood disorders.